A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors

Inclusion Criteria

• Histologic Documentation: Histologic documentation of malignant pheochromocytoma or related tumors (paraganglioma, neuroblastoma, medullary thyroid carcinoma, carcinoid tumors), not amenable to curative surgery. Any site of origin of malignant pheochromocytoma, including but not limited to: adrenal, neck, thorax, abdominal, or pelvis is allowed.
• Prior Treatment:
• No cytotoxic chemotherapy for at least 3 weeks prior to high-dose 131I-MIBG or concurrent with high-dose 131I-MIBG.
• > 2 weeks since major surgery.
• > 4 weeks since completion of prior radiation therapy, as long as measurable disease lies outside the radiation port.
• No treatment with an investigational agent concurrent or within 30 days of high-dose 131I-MIBG.
• Patients who have received previous chemotherapy or radiation therapy must have evidence of persistent disease on 123I-MIBG scan and elevated tumor markers or measurable CT lesions before receiving high-dose 131I-MIBG.
• Metastases Excluding Eligibility: No patients with a known significant MIBG-avid parenchymal brain metastasis; leptomeningeal metastases do not exclude eligibility. Hepatic metastases exclude eligibility if they functionally impair liver function (AST or total bilirubin ≥ 2.5 times the ULN).
• Measurable Disease Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 10 mm as measured with CT scanning. Lesions /= 1,000/micronL
• Platelet count >/= 80,000/micronL
• AST (SGOT) ≤ 2.5 x ULN
• Total bilirubin ≤ 2.5 x ULN
• Creatinine ≤ 2 x ULN

Exclusion Criteria

• 1) Pregnancy & Nursing: Non-pregnant and non-nursing because the effects of high-dose 131I-MIBG on the fetus/infant are unknown.
• 2) Second Malignancies:
• Patients with a "currently active" second malignancy, other than non-melanoma skin cancers, are not eligible.
• Patients are not considered to have a "currently active" second malignancy if they have been cancer-free for ≥5 years
• 3) Intercurrent Illness: No patients with uncontrolled intercurrent illness including but not limited to: ongoing active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.